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FDA investigates Diabetes Drug Metformin
FDA investigates Diabetes Drug Metformin and is testing the popular Type-2 Diabetes medication, for a cancer-causing chemical has contaminated the drug.
Laboratory analysis of metformin products
FDA investigates Diabetes Drug Metformin for the presence of the N-Nitrosodimethylamine (NDMA) impurity in metformin approved for sale in the U.S. Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes. FDA testing has found NDMA in certain lots of extended release (ER) metformin and is recommending companies recall lots with levels of NDMA above the acceptable intake limit of 96 nanograms per day.
FDA is posting its laboratory results in the table below showing NDMA amounts in metformin products it tested. FDA is also collaborating with international regulators to share testing results for metformin.
For reference, consuming up to the acceptable daily intake limit, 0.096 micrograms (96 nanograms), of NDMA per day is considered reasonably safe for human ingestion based on lifetime exposure. NDMA may increase the risk of cancer if people are exposed to it above the acceptable level and over a long period of time, but a person taking a drug that contains NDMA at-or-below the acceptable daily intake limit every day for 70 years is not expected to have an increased risk of cancer.
The carcinogen N-Nitrosodimethylamine (NDMA). The FDA says the levels of NDMA in these medications are within the range of what naturally occurs in some foods and water.
“While we are aware that some regulatory agencies outside the U.S. may be recalling some metformin drugs, there are no metformin recalls affecting the U.S. market at this time,”
Dr. Janet Woodcock said in a statement released by the administration.
“The FDA is investigating whether metformin in the U.S. market contains NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms.”
If you have questions about the investigation, you can call the FDA at 888-INFO-FDA.
